MPGL10CB

Gamma Compatible Millipak^® -100

pore size 0.22 μm, filtration area 500 cm², matrix Durapore^®

• 동의어(들): Gamma Compatible Millipak^®-100 Filter Unit 0.22 µm 1/4 in. NPTM
• UNSPSC 코드: 23151806

속성

• material: PVDF
• Quality Level: 400
• 무균: sterile
• 제품 라인: EMPROVE^® Filter
• 특징: hydrophilic
• 제조업체/상표: Millipak^®
• 여과 면적: 500 cm²
• 입구 연결 직경: 1/4 in.
• 출구 연결 직경: 1/4 in.
• 불순물: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 중량 추출물: ≤2.5 mg/device
• 기질: Durapore^®
• 공극 크기: 0.22 μm pore size
• 피팅: NPT inlet connection; NPT outlet connection

설명

일반 설명

Device Configuration: Capsule

Number of stacked discs: 100 discs

기타 정보

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Directions for Use

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

제조 메모

Sterilization Method
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

분석 메모

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

Gravimetric Extractables: after 24 hours in water at controlled room temperature

법적 정보

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany